Senior Director, Biostatistics

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Opportunity to Make a Difference

• Provide statistical strategies and expertise for clinical development, regulatory submission, and patient access data generation for the assigned clinical development program or functional areas
• Be accountable for all statistical aspects of assigned clinical development programs or functional area, including clinical development plans, protocols and regulatory submissions
• Oversee collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of Biometrics or Biostatistics deliverables from internal and external teams (e.g., CRO) that meet their objectives while complying with regulations and quality standards
• Effectively interact with members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
• Lead/oversee optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, and to address identified or potential statistical issues arising in studies or programs
• Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs
• Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures, and listings
• Represent Sarepta regarding statistical issues with external parties including regulatory agencies and corporate partners
• Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Review case report form (CRF) designs to ensure data collection meets the requirements of statistical analyses
• Design and specify randomization schedules; review and approve test randomization lists
• Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
• Perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
• Contribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement efforts
• Participate in development and implementation of functional or cross-functional SOPs for process simplification, standardization or improvement
• Develop and lead a team of high performing biostatisticians to meet corporate, R&D, and program goals
• Champion a modern analytics operating model that pairs pre-specified confirmatory analyses with fit-for-purpose exploratory analytics, enabling the team to interrogate data rapidly while maintaining regulatory defensibility
• Partner closely with Clinical Development, Medical Affairs, and Regulatory to translate emerging scientific questions into actionable exploratory analysis plans, ensuring Biometrics is embedded in decision-making, not just reporting
• Lead rapid-response analytical efforts (e.g., post-readout deep dives, ad-hoc regulatory queries) with clear scientific triage, prioritization, and interpretation under compressed timelines
• Define governance guardrails for exploratory work, including risk-based validation, documentation standards, and clear separation from submission-quality deliverables, so the team can move fast without creating compliance debt
• Foster a culture where biostatisticians are hands-on analysts and scientific architects, not solely oversight managers, personally engaging with data exploration using modern tools (R, Python, interactive visualization) alongside traditional SAS workflows

More about You

• Ph.D. in statistics or related discipline with 11+ years, or Master's Degree with 13+ years of experience in the pharmaceutical or biotech industry
• Experience of providing statistical leadership for clinical development programs
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials
• Experience leading NDAs, MAAs or other regulatory submissions
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
• Knowledge of FDA, EMA and ICH regulations and guidelines
• Knowledge of immunology and/or gene therapy is desirable, but not required
• Experience with external control arms, real-world data, or causal inference methods is a plus
• Proficient in statistical programming in SAS and R; Python and other languages a plus
• Experience with trial design software (e.g., EAST)
• Ability to concurrently lead or coordinate statistical efforts for multiple projects
• Understanding of data standards, including SDTM and ADaM
• Adept at overseeing statistical services provided by CROs
• Ability to communicate statistical information to non-scientists, willingness to educate internal team
• Experience in managing a Biostatistics or Biometrics team and overall resource planning
• Comfort operating in a dual-track model: formal SAP-driven analyses alongside agile, hypothesis-driven exploration
• Enthusiasm for harnessing modern AI tools and workflows, and willingness to champion their responsible adoption across the Biometrics team
• Track record of partnering with clinical development teams as a strategic thought partner, not just a service function

What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.